Market intelligence: Reach phase II data in doubt

19 April 2013 09:29[Source: ICB]

As winter in Europe starts to grudgingly give way to spring, the warmth of the lengthening evenings and the blossom dotting the trees will remind compliance officers all over Europe that the deadline for the next phase of Reach, the European Chemical Agency's (ECHA's) grand, costly chemicals registration project, is approaching.

Phase 2 of Reach registration, due on 31 May this year, covers the registration of chemicals used by companies in quantities from over 100 tonnes.

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Reach phase 2 is proving to be a challenge

The previous registration, for chemicals used in quantities of 1,000 tonnes or more, was beset by technical difficulties as the new system struggled with the volume and size of registration dossiers.

Technical issues are less likely to be a problem this time around according to ECHA executive director Geert Dancet, who predicted that the improved technical infrastructure and lower submission volumes should reduce the issues experienced by registrants in 2010.

"We do not expect any technical hiccups at all, because that volume is not comparable in size with the 2010 deadline, and the size of each individual registration is also smaller, as there is less information to submit," Dancet said, speaking on the sidelines of ECHA's eighth annual stakeholder meeting in Helsinki, Finland on 26 March.

Dancet is predicting a total of 7,600 registrations by 31 May, of which 3,400 had been received at the time of the stakeholder meeting. At under half the projected total just over eight weeks before the deadline, making up that shortfall sounds like a tall order. But 10 of the largest chemical companies in Europe are expected to submit their lead registrant dossiers a little ahead of the general deadline.

REGISTRATION ISSUES

However, it is becoming increasingly clear that a significant proportion of the expected registrations may miss the 31 May deadline, at least in terms of the materials being registered.

Of the 3,083 substances expected to be registered for the first time in May, there are 626 for which ECHA had received neither a lead registration nomination nor a registration as of the end of March, according to ECHA dossier submission unit head Kevin Pollard.

Also significant is that, despite the technical improvements, the quality of registration submissions has been an issue in the past, and continues to be an issue.

According to Christel Musset, the agency's director of registration, a substantial proportion of the dossiers submitted for the first Reach deadline on 30 November 2010 had anomalies of varying degrees of severity.

A figure has not been disclosed for the 26,000 phase 1 registrations, but Musset revealed that of the 5,500 registration dossiers submitted for intermediates - materials that are not sold on the general market but are used in manufacturing - 2,388 dossiers were not of a high enough standard to be fully compliant.

2,090 of those dossiers have since been revised - although Musset did not elaborate on how many of those are now compliant - but it is hard to imagine the situation being substantially improved this time around. 25% of phase 2 registrants are expected to be SMEs, many of which will not have been through the process before and may be less equipped to deal with it than the larger companies that went through phase 1.

Musset said: "The first registration deadline brought a wealth of information, and [there] has been good progress, because it's the first time that we [have] had so much information on the chemicals that are in the European market.

"But what we have been seeing in our evaluation work [is that] we are not there yet. There is still room for improving the information that we are receiving, so that's why quality of information was brought so high up in our agenda," she added.

According to the agency's 2012 progress report on evaluation under the Reach legislation, the ECHA was able to close the books on just 33% of the 354 compliance checks that it carried out during 2012.

Leena Yla-Mononen, ECHA's director of evaluation, said that issues with registration extend as far as being able to identify the substance the dossier is being submitted for.

She said: "What was a revelation is that we had to do compliance checks on substance identity in so many cases before being able to conclude on the testing proposal. So that was a bit of a surprise, that 20% of the dossiers where there was a testing proposal, substance identity was too unclear to be able to conclude [on the proposal].

"We didn't set the bar very high there, but we needed to know what the substance was before proceeding," she added.

There are issues on ECHA's side too. The agency has scrambled to reduce the cost for small and medium-sized enterprises (SMEs) in recent months, as even the European Commission's most recent progress report on Reach concluded that the impact on smaller companies was disproportionate.

SME REDUCTIONS

Registration fee reductions of up to 95% for SMEs have been at least partially floated by price hikes of 4% for registrations and 3.5% for authorisations for large companies, although no financial assistance for smaller companies has been mentioned at this point in terms of the testing side of the registration process.

Substance Information Exchange Forums (SIEFs) - which companies are legally obligated to join if registering the same substance - were set up to address cost issues and reduce the replication of the same research, but costs associated with obtaining registration documents from other SIEF members can represent over half of an SME's registration costs.

To partially address this, ECHA is providing assistance and training to some SMEs to help them act as lead registrants for certain SIEFs, but a question mark still hangs over whether those SMEs will have enough expertise in-house to deal with the complexities of coordinating a substance registration.

The cataloguing and registration of every chemical used by every company in the EU is a titanic project, both in scope and cost, and adapting to the requirements of the regulators and of the industry itself will take time. But with issues still hanging over some of the registrations from 2010, it seems unlikely these issues will have been fully dealt with by 31 May or by the final deadline in 2018.